Governance
Access to national patient data is a responsibility, not a right. Governance defines the legal and operational envelope for every connected partner.
The legal basis, agreements, consent obligations, and audit requirements that apply to every certified technical partner, including consequences of non-compliance.
Statutory basis
Partner integrations are expected to align with the policy and legal framework referenced by the NHIE program, including national health legislation, data protection requirements, and interoperability framework obligations.
Compliance to implementation mapping
| Compliance obligation | What partner systems must do |
|---|---|
| NHI Act basis for centralized exchange | Document and constrain each data flow to approved service scope |
| National Health Act confidentiality obligations | Enforce confidentiality, access control, and protected handling in-app |
| POPIA special-category processing rules | Maintain processing records, breach process, and data subject rights workflow |
| HNSF conformance obligations | Implement SA FHIR IG profiles and pass conformance suites |
Data sharing obligations
The Data Sharing Agreement is the binding contract between NDoH and a technical partner organization. No production access is issued without an approved agreement.
In scope
- System integration for approved clinical and operational purposes
- Data exchange required by the signed integration scope
- Security, audit, and compliance controls for all accessed records
Out of scope
- Commercial resale or onward licensing of NHIE-sourced data
- Use outside approved purpose in the signed agreement
- Aggregation patterns that can re-identify individuals
DSA process
- Request and review the template.
- Complete internal legal and information-officer sign-off.
- Submit for NDoH legal review.
- Receive counter-signature and credential path decision.
- Renew annually with updated compliance attestation.
Data governance rules
- Use data only for the named purpose in your agreement
- Do not perform unauthorized onward sharing
- Meet de-identification requirements for secondary use
- Maintain ATNA-conformant audit trails
- Honor consent and access decisions at point of care
Consequences of non-compliance
Depending on severity and recurrence, outcomes may include written remediation notices, suspension of production access, revocation of certification, and statutory penalties under applicable law.
Operational compliance
- Production credentials are conditional on continuing conformance
- Partners must maintain auditable controls and incident reporting readiness
- Governance updates should be monitored and implemented within stated windows